Residues of Quaternary Ammonium Compounds, N-Alkyl (C12-18, 49101-49107 [E8-19070]
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Federal Register / Vol. 73, No. 162 / Wednesday, August 20, 2008 / Rules and Regulations
rule, we also requested comments on its
collection of information provisions.
The rule’s § 169.215 of 33 CFR
requires ships to transmit position
reports using long range identification
and tracking (LRIT) equipment that has
been type-approved by their
Administration. Its § 169.230 of the
same title requires ships’ LRIT
equipment to transmit position reports
at 6-hour intervals unless a more
frequent interval is requested remotely
by an LRIT Data Center. And its
§ 169.245 requires a ship’s master to
inform his or her Flag Administration
without undue delay if LRIT equipment
is switched off or fails to operate. The
master must also make an entry in the
ship’s logbook that states his or her
reason for switching the LRIT
equipment off, or an entry that the
equipment has failed to operate, and the
period during which the LRIT
equipment was switched off or nonoperational.
The LRIT NPRM and final rule are
available electronically through the
docket (USCG–2005–22612) at
www.regulations.gov. On August 12,
2008, under 44 U.S.C. 3505(c), OMB
approved the collection of information
associated with the requirements in
§§ 169.215, 169.230, and 169.245 of the
LRIT final rule under OMB control
number 1625–0112. A copy of the OMB
notice of action is available in our
online docket.
Dated: August 15, 2008.
Howard L. Hime,
Acting Director of Commercial Regulations
and Standards, U.S. Coast Guard.
[FR Doc. E8–19307 Filed 8–19–08; 8:45 am]
BILLING CODE 4910–15–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0573; FRL–8376–9]
Residues of Quaternary Ammonium
Compounds, N-Alkyl (C12-18) dimethyl
benzyl ammonium chloride on Food
Contact Surfaces; Exemption from the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
sroberts on PROD1PC70 with RULES
AGENCY:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of n-alkyl (C12-18)
dimethyl benzyl ammonium chloride
(CAS No. 68424–85–1) on food contact
surfaces when applied/used in public
eating places, dairy processing
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equipment, and/or food processing
equipment and utensils. The regulation
will exempt from the requirement of
tolerance residues in food resulting from
contact with surfaces treated with
antimicrobial solutions where the enduse concentration of active quaternary
compound does not exceed 400 ppm.
DATES: This regulation is effective
August 20, 2008. Objections and
requests for hearings must be received
on or before October 20, 2008, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0573. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either in the electronic docket
at https://www.regulations.gov, or, if only
available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Velma Noble, Antimicrobials Division
(7510P), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (703) 308–6416; e-mail address:
noble.velma@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are dairy cattle milk
producer, food manufacturer, or
beverage manufacturer. Potentially
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affected entities may include, but are
not limited to:
• Dairy Cattle Milk Production
(NAICS code 11212).
• Food manufacturing (NAICS code
311).
• Beverage Manufacturing (NAICS
code 3121).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, as
amended by FQPA, any person may file
an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2006–0573. in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before October 20, 2008.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
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may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2006–0573., by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
sroberts on PROD1PC70 with RULES
II. Petition for Exemption
In the Federal Register of November
28, 2007 (72 FR 67299) (FRL–8141–1),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide tolerance petition (PP 6F7071)
by Edwards-Councilor Co., Inc, 1427
Baker Road Virginia Beach, VA 23455.
The petition requested that 40 CFR
180.940(a) be amended by increasing
concentration limits for n-alkyl (C12-18)
dimethyl benzyl ammonium chloride in
end-use solutions eligible for tolerance
exemption. That notice referenced a
summary of the petition prepared by
Edwards-Councilor Co., Inc, the
registrant, which is available to the
public in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Based upon review of the data
supporting the petition, EPA has created
a new exemption n-alkyl (C12-18)
dimethyl benzyl ammonium chloride
(CAS No. 68424–85–1) instead of
amending the current exemption for the
sake of clarity. The reason for this
change is explained in Unit IV.B.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
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result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Pursuant to
section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in section
408(b)(2)(C) of FFDCA, which requires
EPA to give special consideration to
exposure of infants and children to the
pesticide chemical residue in
establishing a tolerance and to ‘‘ensure
that there is a reasonable certainty that
no harm will result to infants and
children from aggregate exposure to the
pesticide chemical residue . . . .’’
Consistent with section 408(c)(2)(A)
of FFDCA, and the factors specified in
section 408(c)(2)(B) of FFDCA, EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
exemption from the requirement for a
tolerance for residues of alkyl (C12-18)
dimethyl benzyl ammonium chloride on
food contact surfaces when applied/
used in public eating places, dairy
processing equipment, and/or food
processing equipment and utensils.
EPA’s assessment of exposures and risks
associated with amending the
exemption from the requirement for a
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by alkyl (C12-18) dimethyl benzyl
ammonium chloride as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
are discussed in this unit.
The alkyl dimethyl benzyl ammonium
chlorides(ADBAC) chemical case is
comprised of 24 compounds that are
structurally similar quaternary
ammonium compounds (quats) that are
characterized by having a positively
charged nitrogen covalently bonded to
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three alkyl group substituents (two
methyls and R component) and a benzyl
substituent. The R component
represents the different number of
hydrocarbon carbon moieties delineated
by different percentages (i.e. Alkyl (50%
C14, 40% C12, 10% C16) dimethyl benzyl
ammonium chloride. In finished form,
these quats are salts with the positively
charged nitrogen (cation) balanced by a
negatively charged anion. The most
common anion for the quats in this
cluster is chloride. However, other
anions, such as saccharide and bromide
are also used. The Agency clustered
these chemicals together because
variance in the length and conformation
of alkyl carbon chains between 12 and
18 does not appear to significantly affect
the toxicity or fate of ADBAC
compound.
In all ADBACs, it is the positive entity
(quaternized nitrogen) that is of
relevance from toxicology and exposure
perspectives. The negative part of
ADBAC (counter ion) is a relatively nontoxic entity (chloride). Alkyl (50% C14,
40% C12, 10% C16) dimethyl benzyl
ammonium chloride (PC code 069105)
was chosen by the Agency as the
representative chemical for Group II,
ADBAC, and the toxicology database for
PC code 069105 is being considered
representative of the hazard for the
ADBAC class of quaternary ammonium
compounds. The individual exposure
scenarios in the ADBAC assessments (as
well as the aggregate assessment in the
RED) were developed by assuming that
an ADBAC compound was used on 100
percent of the surfaces authorized on
the label that could result in human
exposure and summing the percent
active ingredients (a.i.) on the labels for
all of the ADBAC compounds when
used in combination.
ADBACs are corrosive, highly
irritating to the eye and skin, with
moderate acute toxicity by oral, dermal,
and inhalation routes of exposure.
These chemicals are classified as ‘‘not
likely’’ to be human carcinogens based
on negative carcinogenicity studies in
both rats and mice. There is no evidence
of these chemicals being associated with
increased susceptibility to
developmental toxicity or reproductive
toxicity based on two developmental
toxicity studies and a 2–generation
reproductive study. Lastly, they are
negative for mutagenicity and
neurotoxicity. Specific information on
the studies received and the nature of
the toxic effects caused by ADBAC, can
be found at https://www.regulations.gov.
Docket ID Number EPA–HQ–OPP–
2005–0339, Alkyl dimethyl benzyl
ammonium chloride (ADBAC)- Report
of Antimicrobials Division Toxicity
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Endpoint Committee (ADTC) and the
Hazard Identification Assessment
Review Committee (HIARC).
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
effects are observed (the NOAEL) in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a Benchmark Dose
(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction
with the POD to take into account
uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. The Level of Concern (LOC)
is a reference value expressed as either
a reference dose/population adjusted
dose (RfD/PAD) or margin of exposure
(MOE). Safety is assessed for acute and
chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the POD by all applicable
uncertainty/safety factors. Aggregate
short-, intermediate-, and chronic-term
risks are evaluated by comparing food,
49103
water, and residential exposure to the
POD to ensure that the MOE called for
by the product of all applicable UFs is
not exceeded.
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk and
estimates risk in terms of the probability
of a cancer occurrence greater than that
expected in a lifetime. Generally, cancer
risks are considered non-threshold. For
more information on the general
principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for ADBAC used for human
risk assessment is shown in the Table in
this unit.
SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ADBAC FOR USE IN HUMAN RISK ASSESSMENT
Exposure/Scenario
Point of Departure and Uncertainty/
Safety Factors
Acute dietary (General pop.,
females 13+, infants and
children)
RfD, PAD, LOC for Risk Assessment
Study and Toxicological Effects
An acute dietary endpoint was not identified in the database.
NOAEL = 44 mg/kg/day
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.44 mg/kg/day
cPAD = 0.44 mg/kg/day
Chronic toxicity/
carcinogencity-rat MRID
41947501
LOAEL = 88 mg/kg/day
based on decreased body
weight and weight gain
Incidental oral short-term (1
to 30 days)
NOAEL = 10 mg/kg/day
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Developmental Toxicity-Rat
MRID 42351501
LOAEL = 30 mg/kg/day
based on clinical signs
and decrease body weight
gain
Incidental oral intermediateterm (1 to 6 months)
NOAEL = 10 mg/kg/day
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Developmental Toxicity-Rat
MRID 42351501
LOAEL = 30 mg/kg/day
based on clinical signs
and decrease body weight
gain
Dermal short-term (1 to 30
days) (Formulated product
(4% ai.))
Dermal study
NOAEL = 20 mg/kg/day
(333 µg/cm2)b
UFA = 3 x
UFH = 3x
FQPA SF = 1x
LOC for MOE = 10
d
21–day dermal toxicity-guinea pigs MRID 41105801
LOAEL = 40 mg/kg/day
based on denuded nonvascularized epidermal
layer
Dermal intermediate-term
(technical grade a.i.) (1 to
6 months)
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Chronic dietary (All populations)
Dermal study
NOAEL = 20 mg/kg/day
(80 µg/cm2)c
UFA = 3 x
UFH = 3x
FQPA SF = 1x
LOC for MOE = 10
d
90–day dermal in rats MRID
41499601
LOAEL = 20 mg/kg/day
based on highest doest
tested before irritation became significant. Irritation
not observed until day 43
Dermal Short-term (technical
grade a.i)
No endpoint identified from the available data on dermal irritation. Dermal irritation in the 90–day dermal toxicity study was not evident until day 43 (MRID 41499601)d
Long-Term Dermal (technical
grade a.i.)
No appropriate endpoint identified. No systemic effects observed up to 20 mg/kg/day, highest dose of technical
that could be tested without irritation effects.d
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SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ADBAC FOR USE IN HUMAN RISK ASSESSMENT—Continued
Exposure/Scenario
Inhalation (all exposures)
Point of Departure and Uncertainty/
Safety Factors
Oral study NOAEL = 3 mg/kg/day
100%)
UFA = 10x
UFH = 10 x
UF =10xa
FQPA SF = 1x
RfD, PAD, LOC for Risk Assessment
LOC for MOE = 1,000
Study and Toxicological Effects
Developmental Toxicity-rabbit MRID 42392801
LOAEL = 9 mg/kg/day based
on clinical signs of toxicity
in maternal animals
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population
(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.
a An additional uncertainity factor of 10x is applied for use of an oral endpoint for route-to-route extrapolation to determine if a confirmatory inhalation toxicity study is warranted.
b Formulated-based dermal endpoint = (20 mg/kg guinea pig x 0.43 kg guinea pig x 1,000 µg/mg)/ 25.8 cm2 area of guinea pig dosed = 33 µg/
cm2.
c TGAI-based dermal endpoint = (20 mg/kg rat x 0.2 kg rat x 1,000 µg/mg)/ 50 cm2 area of rate dosed = 80 µg/cm2.
d For dermal exposures, irritation as the effect was selected for the short-term endpoint and a reduced margin of exposure (MOE) was used to
characterize the risk. The use of irritation as a toxic endpoint for assessment of dermal risk is appropriate in this case, as dermal exposure that
results in primarily an irritation response is considered a self-limiting type of exposure that is not expected to last for any length of time, and variability in the response is not expected to be as great as systemic toxic responses. For ADBAC, the MOE for short-term dermal risk is reduced to
a total factor of 10x( 3x for interspecies extrapolation, 3x for intraspecies variation
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to n-Alkyl (C12-18) Dimethyl
Benzyl Ammonium Chloride, EPA
considered exposure under the
petitioned-for exemption as well as all
existing ADBAC exemptions or
tolerances in (40 CFR 180.940(a), and
(c)). EPA assessed dietary exposures
from ADBAC in food as follows:
ADBACs are to be used as a sanitizer
on counter tops, utensils, appliances,
tables, refrigerators, food packaging, and
beverage bottling. The use of these
actives in antimicrobial products for use
on food or feed contact surfaces,
agricultural commodities, and
application to food-grade eggs may
result in pesticide residues in human
food. Residues from treated surfaces,
such as utensils, countertops,
equipment, and appliances can migrate
to food coming into contact with the
treated and rinsed surfaces and can be
ingested by humans.
The Agency assessed chronic dietary
exposures from the use of ADBAC as a
disinfectant and food contact sanitizer
on utensils, countertops, and in food/
beverage processing facilities. The
assessment calculated the Daily Dietary
Dose (DDD) and the Estimated Daily
Intake (EDI) using modified FDA
methodologies for utensils and Indirect
Dietary Residential Exposure Model
software (IDREAM) for countertops.
IDREAM incorporates consumption data
from USDA’s Continuing Surface of
Food Intakes by Individuals (CSFII) for
1994–1996, and 1998. The 1994–1996,
and 1998 data are based on the reported
consumption of more than 20,000
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individuals over two non-consecutive
survey days.
The Estimated Daily Intake (EDI)
calculations presented in this
assessment for treated indirect dietary
exposures resulting from sanitizing
utensils assumed that food would
contact 4,000 cm2 (which represents
contact with treated silverware, china,
and glass used by an individual who
regularly eats three meals per day at an
institutional or public facility) and that
the residual solution remaining on the
surface or pesticide migration fraction is
1 milligram (mg) per square centimeter
of treated area. The body weights used
for this assessment were 70 kilogram
(kg) for an adult male, 60 kg for an adult
woman, and 10 kg for an infant. Based
on data provided in a new residue
study, Transferability Equivalence
among Quats and Measured Food
Surrogate Transfer Efficiency (MRID
46870703), a conservative transfer rate
of 43% was used to estimate the amount
of residues on the surface that will be
transferred to food and subsequently
ingested. The maximum application rate
for ADBAC on utensils is 0.0033 lbs a.i
per gallon of treatment solution.
There are two levels of refinement for
assessing dietary exposure to
antimicrobial products used on
countertops. The three dimensional
approach, Tier 2, was utilized for this
assessment. This conservative approach
uses food consumption and preparation
patterns as well as data and
assumptions that are not chemical
specific. Food ingredients are separated
into nine categories based on food
preparation, food physical properties,
and potential, or likelihood of contact
with treated countertops. The nine food
categories are liquids, fruit, bread,
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cheese, vegetable, meat, purees (e.g.,
pudding, oatmeal), pieces (foods
normally consumed in small pieces),
and powders (foods normally used in
powder/granular forms). Assumed
countertop residues are converted to
estimated residues contacting the
countertops using a translation factor for
each food category, and default residue
transfer efficiency for a representative
food. Therefore, IDREAM combines the
estimated countertop residues for
surface treatment products, CSFII
consumption data, food-specific
conversion factors that relate the surface
area contacting a countertop with
corresponding weight of the food item,
and the transfer efficiency of residues
from countertops to food. Conservative
assumptions for these analyses include:
All disinfectants registered to disinfect
kitchen countertops are included; all
foods are prepared on treated
countertops; all prepared foods will
come in contact with treated
countertops at the maximum active
ingredient residues; these residues will
not diminish over time (i.e. residue
reduction will not occur from cooking
or preparation processes); there is a
100% likelihood of contact to account
for both commercial and residential
scenarios; all commercial facilities and
households use the same disinfectant
product; all foods are prepared and
consumed.
When assessing the food bottling/
packaging use, EPA assumed a 100%
transfer rate because the food is
potentially in contact with the treated
surfaces for very long periods of time.
The maximum application rate for
ADBAC for bottling/packing of food is
0.0103 lbs a.i per gallon of treatment
solution. EDI values were calculated
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using an approach similar to that used
for treated food utensils. Exposure was
assumed to occur through the ingestion
of three food products that might be
packaged in treated material: Milk, egg
products, and beverages (alcoholic and
non-alcoholic). A calorie intake
modification factor of 0.64 was applied
to the EDI for a child to account for the
differences between intake values
among children and adults. The
calculated % cPADs for all population
subgroups do not exceed 100% and
therefore are not of a concern.
2. Dietary exposure from drinking
water. ADBAC is applied to nursery
ornamentals and turf as an bactericide
and fungicide. The Tier 1 surface water
and ground water model was used to
assess Estimated Drinking Water
Concentrations (EDWCs). EPA modeled
the ornamental plant use because this
use has the highest application rate of
all labeled uses — 302 lbs. a.i/Acre, and
a maximum of three applications per
year. The EDWCs determined for the
nursery ornamental use are also
protective of all other uses with lower
application rates. The EDWC for surface
water is 331 microgram/Liter (µg/L) and
ground water is 5.4 µg/L. There were no
major degradates of ADBAC in the
laboratory studies.
ADBAC is also used for mosquito
control and as an algaecide in
decorative ponds and pools. Because the
mosquito control and algaecide uses are
both periodic in nature and are
restricted to a limited use area, EPA
expects drinking water exposures from
these uses to be minimal in comparison
to the ornamental plant exposure
estimate for drinking water using the
tier I surface and ground water model.
Additionally, antisapstain and cooling
water tower uses for ADBAC are
potential exposures to drinking water.
These uses are also expected to result in
minimal exposure in comparison to the
modeled EDWCs for the ornamental use
taking into account that the Tier 1
model assumed that ADBAC was
applied at 302 pounds/acre across the
entire watershed.
Specific information on the dietary
and drinking water exposure
assessments for ADBAC can be found at
https://www.regulations.gov. Docket ID
Number EPA–HQ–OPP–2006–0339
Dietary Risk Assessment on ADBAC and
Tier 1 Drinking Water Assessment for
Alkyl Dimethyl Benzyl Ammonium
Chloride (ADBAC) and Didecyl
Dimethyl Ammonium Chloride (DDAC).
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
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carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
ADBAC is currently registered for the
following residential non-dietary sites:
Homes, swimming pools, humidifiers.
EPA assessed residential exposure using
the following assumptions: Residential
exposure may occur during the
application as well as post application
of ADBAC to indoor hard surfaces (e.g.,
mopping, wiping, trigger pump sprays),
carpets, swimming pools, wood as a
preservative, textiles (e.g., diaper treated
during washing and clothes treated with
fabric spray), and humidifiers. The
residential handler scenarios were
assessed to determine dermal and
inhalation exposures. Residential post
application scenarios such as children
exposure to treated toys and floors were
also assessed to determine dermal and
incidental oral exposures. Surrogate
dermal and inhalation unit exposure
values were estimated using Pesticide
Handler Exposure Database (PHED) data
and the Chemical Manufactures
Association Antimicrobial Exposure
Assessment Study (USEPA, 1999), and
the SWIMODEL 3.0 was utilized to
conduct exposure assessments of
pesticides found in swimming pools
and spas (Versar, 2003). Note that for
this assessment, EPA assumed that
residential users complete all elements
of an application (mix/load/apply)
without the use of personal protective
equipment.
The duration for most residential
exposures is believed to be best
represented by the short-term duration
(1 to 30 days). The short-term duration
was chosen for this assessment because
the residential handler and postapplication scenarios are assumed to be
performed on an episodic, not daily
basis.
Specific information on the
residential exposure assessment for
ADBAC Quaternaries can be found at
https://www.regulations.gov. Docket ID
Number EPA–HQ–OPP–2006–0339
Alkyl Dimethyl Benzyl Ammonium
Chloride (ADBAC) Occupational and
Residential Exposure Assessment.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA’s risk assessment for any
individual ADBAC is based on an
assessment of the cumulative exposure
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Sfmt 4700
49105
to all ADBACs. The individual exposure
scenarios in the ADBAC assessments (as
well as the aggregate assessment in the
RED) were developed by assuming that
an ADBAC compound was used on 100
percent of the surfaces authorized on
the label that could result in human
exposure and summing the percent
active ingredients on the labels for all of
the ADBACs when used in combination.
Thus, because the risk assessment for
ADBAC accounts for exposures to all of
the ADBACs, there is no need for a
separate cumulative risk assessment for
those compounds. The Agency has not
identified any other substances as
sharing a common mode of toxicity with
ADBAC. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional (10X) tenfold margin of safety
for infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA SF. In applying this provision,
EPA either retains the default value of
10X when reliable data do not support
the choice of a different factor, or, if
reliable data are available, EPA uses a
different additional FQPA SF value
based on the use of traditional UFs and/
or FQPA SFs, as appropriate.
2. Prenatal and postnatal sensitivity.
There is no evidence that ADBAC result
in increased susceptibility in in utero
rats or rabbits in the prenatal
developmental studies or in young rats
in the 2–generation reproduction study.
3. Conclusion. EPA has determined
that reliable data show that it would be
safe for infants and children to reduce
the FQPA SF to 1X. That decision is
based on the following findings:
i. The toxicity database for ADBAC
pertaining to the risks to infants and
childrenis complete.
ii. There is no indication that ADBAC
is a neurotoxic chemical and there is no
need for a developmental neurotoxicity
study or additional UFs to account for
neurotoxicity.
iii. There is no evidence that ADBAC
results in increased susceptibility in in
utero rats or rabbits in the prenatal
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Federal Register / Vol. 73, No. 162 / Wednesday, August 20, 2008 / Rules and Regulations
developmental studies or in young rats
in the 2–generation reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
Conservative ground water and surface
water modeling estimates were used.
Similarly conservative residential
standard operating procedures (SOPs)
were used to assess post-application
exposure of children as well as
incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by ADBAC.
E. Aggregate Risks and Determination of
Safety
The chronic dietary aggregate risk
assessment includes direct and indirect
food contact uses as well as drinking
water exposures. Based on the results of
the chronic aggregate assessment, the
estimated chronic risks for adults and
children are 8.4% and 40.9% of the
respective cPADs. Therefore, the
chronic dietary aggregate risks are not of
concern (i.e., less than 100% of cPAD).
Short-term and intermediate-term
aggregate risks were calculated using the
total MOE approach. Only the shortterm aggregate is presented here because
the endpoints for incidental oral as well
as inhalation are identical for the shortand intermediate-term durations.
Moreover, EPA has not identified that
aggregate risks are not of concern for
adults for any of the three routes of
exposure. The aggregate adult MOEs are
1,200 for oral, 480 for dermal, and 2,000
for inhalation, which are greater than
the target MOE of 100 for the oral, 1,000
for inhalation, and 10 for dermal. For
children, the aggregate risk estimate for
each of the routes of exposure are also
above the target MOEs of 100 for the
oral, 1,000 for inhalation, and 10 for
dermal (MOE = 140 for the oral route,
1,200 for the dermal route, and no cooccurrence for the inhalation route), and
thus are not of concern.
Based on the toxicological and
exposure data discussed in this
preamble, EPA concludes that ADBAC
will not pose a risk under reasonably
foreseeable circumstances. Accordingly,
EPA finds that there is a reasonable
certainty of no harm will result to the
general population, or to infants and
children from aggregate exposure to
ADBAC residues.
IV. Other Considerations
sroberts on PROD1PC70 with RULES
A. Analytical Enforcement Methodology
An analytical method for food is not
needed for enforcement purposes. Food
contact sanitizers are typically regulated
by the State health departments to
ensure that the food industry is using
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15:02 Aug 19, 2008
Jkt 214001
products in compliance with the
regulations in 40 CFR 180.940. The enduse solution that is applied to the food
contact surface is analyzed, rather than
food items that may come into contact
with treated surface. An analytical
method is available to analyze the use
dilution that is applied to food contact
surfaces. A titration method is used to
determine the total amount of
quaternary compound. If the use
solution is a mixture of ADBAC and
didecyl dimethyl ammonium chloride
(DDAC), then High Pressure Liquid
Chromatogram–Ultraviolet Visible
(HPLC-UV) is used to determine the
amount of ADBAC. The amount of
DDAC is determined by calculating the
difference between the total amount of
quaternary compounds and ADBAC.
B. Revisions to Petitioned-For
Exemption
EPA has revised the exemption as
proposed in the notice of filing. The
petitioner proposed to amend the
exemption for Quaternary Ammonium
Compounds: N-alkyl (C12-18) dimethyl
benzyl ammonium chloride by
increasing the amount of quaternary
chemicals that may be in end-use
concentrations from 200 ppm to 400
ppm. There presently exists an
exemption for Quaternary Ammonium
Compounds: Alkyl (C12-18) dimethyl
benzyl ammonium chloride (CAS Reg.
No. 8001–54–5) that limits the
concentration of quaternary chemicals
to 200 ppm; however, because the
petitioner specifically sought an
exemption for Quaternary Ammonium
Compounds: N-alkyl (C12-18) dimethyl
benzyl ammonium chloride (CAS Reg.
No. 68424–85–1) with a limit for the
concentration of quaternary chemicals
at 400 ppm, EPA has not amended the
existing exemptions but instead
established a new exemption for
Quaternary Ammonium Compounds: Nalkyl (C12-18) dimethyl benzyl
ammonium chloride (CAS Reg. No.
68424–85–1).
V. Conclusion
Therefore, an exemption from the
requirement of a tolerance under section
408 of FFDCA is established for residues
of n-alkyl (C12-18) dimethyl benzyl
ammonium chloride (CAS No. 68424–
85–1), on food contact surfaces resulting
from use as an antimicrobial pesticide
formulation applied to food-contact
surfaces in public eating places, dairy
processing equipment, and food
processing equipment and utensils,
provided that the end-use concentration
of all quaternary chemicals in solution
does not exceed 400 ppm of active
quaternary compound.
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Fmt 4700
Sfmt 4700
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
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Federal Register / Vol. 73, No. 162 / Wednesday, August 20, 2008 / Rules and Regulations
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Alkyl
Dimethyl Benzyl Ammonium Chloride
Quaternaries, Food Additives, FoodContact Sanitizers Pesticides and pests,
Reporting and recordkeeping
requirements.
Dated: August 7, 2008.
Frank Sanders,
Director, Antimicrobials Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.940 is amended by
alphabetically adding a new entry in the
table in paragraph (a) to read as follows:
I
sroberts on PROD1PC70 with RULES
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
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15:02 Aug 19, 2008
Jkt 214001
CAS
Reg. No.
*
*
Quaternary
Ammonium
Compounds:
n-alkyl
(C12-18)
dimethyl
benzyl
ammonium
chloride
*
*
*
*
Limits
*
68424–
85–1
*
*
When ready for
use, the enduse concentration of all quaternary chemicals in solution
is not to exceed
400 ppm of active quaternary
compound.
*
*
*
*
*
*
[FR Doc. E8–19070 Filed 8–19–08; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 679
[Docket No. 071106673–8011–02]
RIN 0648–XJ81
List of Subjects in 40 CFR Part 180
(a) * * *
Pesticide
Chemical
Fisheries of the Exclusive Economic
Zone Off Alaska; Greenland Turbot in
the Aleutian Islands Subarea of the
Bering Sea and Aleutian Islands
Management Area
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
SUMMARY: NMFS is prohibiting directed
fishing for Greenland turbot in the
Aleutian Islands subarea of the Bering
Sea and Aleutian Islands management
area (BSAI). This action is necessary to
prevent exceeding the 2008 Greenland
turbot total allowable catch (TAC) in the
Aleutian Islands subarea of the BSAI.
DATES: Effective 1200 hrs, Alaska local
time (A.l.t.), August 15, 2008, through
2400 hrs, A.l.t., December 31, 2008.
FOR FURTHER INFORMATION CONTACT:
Jennifer Hogan, 907–586–7228.
SUPPLEMENTARY INFORMATION: NMFS
manages the groundfish fishery in the
BSAI according to the Fishery
Management Plan for Groundfish of the
Bering Sea and Aleutian Islands
Management Area (FMP) prepared by
the North Pacific Fishery Management
Council under authority of the
Magnuson-Stevens Fishery
Conservation and Management Act.
Regulations governing fishing by U.S.
vessels in accordance with the FMP
PO 00000
Frm 00023
Fmt 4700
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49107
appear at subpart H of 50 CFR part 600
and 50 CFR part 679.
The 2008 Greenland turbot TAC in
the Aleutian Islands subarea of the BSAI
is 790 metric tons (mt) as established by
the 2008 and 2009 final harvest
specifications for groundfish in the
BSAI (73 FR 10160, February 26, 2008)
and the allocation from the nonspecified reserves (73 FR 40193, July 14,
2008).
In accordance with § 679.20(d)(1)(i),
the Administrator, Alaska Region,
NMFS, has determined that the 2008
Greenland turbot TAC in the Aleutian
Islands subarea of the BSAI will soon be
reached. Therefore, the Regional
Administrator is establishing a directed
fishing allowance of 540 mt, and is
setting aside the remaining 250 mt as
bycatch to support other anticipated
groundfish fisheries. In accordance with
§ 679.20(d)(1)(iii), the Regional
Administrator finds that this directed
fishing allowance has been reached.
Consequently, NMFS is prohibiting
directed fishing for Greenland turbot in
the Aleutian Islands subarea of the
BSAI.
After the effective date of this closure
the maximum retainable amounts at
§ 679.20(e) and (f) apply at any time
during a trip.
Classification
This action responds to the best
available information recently obtained
from the fishery. The Assistant
Administrator for Fisheries, NOAA
(AA), finds good cause to waive the
requirement to provide prior notice and
opportunity for public comment
pursuant to the authority set forth at 5
U.S.C. 553(b)(B) as such requirement is
impracticable and contrary to the public
interest. This requirement is
impracticable and contrary to the public
interest as it would prevent NMFS from
responding to the most recent fisheries
data in a timely fashion and would
delay the closure of Greenland turbot in
the Aleutian Islands subarea of the
BSAI. NMFS was unable to publish a
notice providing time for public
comment because the most recent,
relevant data only became available as
of August 14, 2008.
The AA also finds good cause to
waive the 30-day delay in the effective
date of this action under 5 U.S.C.
553(d)(3). This finding is based upon
the reasons provided above for waiver of
prior notice and opportunity for public
comment.
This action is required by § 679.20
and is exempt from review under
Executive Order 12866.
Authority: 16 U.S.C. 1801 et seq.
E:\FR\FM\20AUR1.SGM
20AUR1
]]>Agencies
[Federal Register Volume 73, Number 162 (Wednesday, August 20, 2008)]
[Rules and Regulations]
[Pages 49101-49107]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19070]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0573; FRL-8376-9]
Residues of Quaternary Ammonium Compounds, N-Alkyl
(C12-18) dimethyl benzyl ammonium chloride on Food Contact
Surfaces; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of n-alkyl (C12-18) dimethyl
benzyl ammonium chloride (CAS No. 68424-85-1) on food contact surfaces
when applied/used in public eating places, dairy processing equipment,
and/or food processing equipment and utensils. The regulation will
exempt from the requirement of tolerance residues in food resulting
from contact with surfaces treated with antimicrobial solutions where
the end-use concentration of active quaternary compound does not exceed
400 ppm.
DATES: This regulation is effective August 20, 2008. Objections and
requests for hearings must be received on or before October 20, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0573. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Velma Noble, Antimicrobials Division
(7510P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-6416; e-mail
address: noble.velma@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are dairy
cattle milk producer, food manufacturer, or beverage manufacturer.
Potentially affected entities may include, but are not limited to:
Dairy Cattle Milk Production (NAICS code 11212).
Food manufacturing (NAICS code 311).
Beverage Manufacturing (NAICS code 3121).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0573. in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before October 20, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
[[Page 49102]]
may be disclosed publicly by EPA without prior notice. Submit your
copies, identified by docket ID number EPA-HQ-OPP-2006-0573., by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Petition for Exemption
In the Federal Register of November 28, 2007 (72 FR 67299) (FRL-
8141-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 6F7071) by Edwards-Councilor Co., Inc, 1427 Baker Road
Virginia Beach, VA 23455. The petition requested that 40 CFR 180.940(a)
be amended by increasing concentration limits for n-alkyl
(C12-18) dimethyl benzyl ammonium chloride in end-use
solutions eligible for tolerance exemption. That notice referenced a
summary of the petition prepared by Edwards-Councilor Co., Inc, the
registrant, which is available to the public in the docket, https://
www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
created a new exemption n-alkyl (C12-18) dimethyl benzyl
ammonium chloride (CAS No. 68424-85-1) instead of amending the current
exemption for the sake of clarity. The reason for this change is
explained in Unit IV.B.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
Consistent with section 408(c)(2)(A) of FFDCA, and the factors
specified in section 408(c)(2)(B) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
exemption from the requirement for a tolerance for residues of alkyl
(C12-18) dimethyl benzyl ammonium chloride on food contact
surfaces when applied/used in public eating places, dairy processing
equipment, and/or food processing equipment and utensils. EPA's
assessment of exposures and risks associated with amending the
exemption from the requirement for a tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by alkyl (C12-18) dimethyl
benzyl ammonium chloride as well as the no-observed-adverse-effect-
level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from
the toxicity studies are discussed in this unit.
The alkyl dimethyl benzyl ammonium chlorides(ADBAC) chemical case
is comprised of 24 compounds that are structurally similar quaternary
ammonium compounds (quats) that are characterized by having a
positively charged nitrogen covalently bonded to three alkyl group
substituents (two methyls and R component) and a benzyl substituent.
The R component represents the different number of hydrocarbon carbon
moieties delineated by different percentages (i.e. Alkyl (50%
C14, 40% C12, 10% C16) dimethyl benzyl
ammonium chloride. In finished form, these quats are salts with the
positively charged nitrogen (cation) balanced by a negatively charged
anion. The most common anion for the quats in this cluster is chloride.
However, other anions, such as saccharide and bromide are also used.
The Agency clustered these chemicals together because variance in the
length and conformation of alkyl carbon chains between 12 and 18 does
not appear to significantly affect the toxicity or fate of ADBAC
compound.
In all ADBACs, it is the positive entity (quaternized nitrogen)
that is of relevance from toxicology and exposure perspectives. The
negative part of ADBAC (counter ion) is a relatively non-toxic entity
(chloride). Alkyl (50% C14, 40% C12, 10%
C16) dimethyl benzyl ammonium chloride (PC code 069105) was
chosen by the Agency as the representative chemical for Group II,
ADBAC, and the toxicology database for PC code 069105 is being
considered representative of the hazard for the ADBAC class of
quaternary ammonium compounds. The individual exposure scenarios in the
ADBAC assessments (as well as the aggregate assessment in the RED) were
developed by assuming that an ADBAC compound was used on 100 percent of
the surfaces authorized on the label that could result in human
exposure and summing the percent active ingredients (a.i.) on the
labels for all of the ADBAC compounds when used in combination.
ADBACs are corrosive, highly irritating to the eye and skin, with
moderate acute toxicity by oral, dermal, and inhalation routes of
exposure. These chemicals are classified as ``not likely'' to be human
carcinogens based on negative carcinogenicity studies in both rats and
mice. There is no evidence of these chemicals being associated with
increased susceptibility to developmental toxicity or reproductive
toxicity based on two developmental toxicity studies and a 2-generation
reproductive study. Lastly, they are negative for mutagenicity and
neurotoxicity. Specific information on the studies received and the
nature of the toxic effects caused by ADBAC, can be found at https://
www.regulations.gov. Docket ID Number EPA-HQ-OPP-2005-0339, Alkyl
dimethyl benzyl ammonium chloride (ADBAC)- Report of Antimicrobials
Division Toxicity
[[Page 49103]]
Endpoint Committee (ADTC) and the Hazard Identification Assessment
Review Committee (HIARC).
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. The Level of Concern (LOC) is a reference
value expressed as either a reference dose/population adjusted dose
(RfD/PAD) or margin of exposure (MOE). Safety is assessed for acute and
chronic dietary risks by comparing aggregate food and water exposure to
the pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable uncertainty/safety factors.
Aggregate short-, intermediate-, and chronic-term risks are evaluated
by comparing food, water, and residential exposure to the POD to ensure
that the MOE called for by the product of all applicable UFs is not
exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of a cancer occurrence greater than that expected in
a lifetime. Generally, cancer risks are considered non-threshold. For
more information on the general principles EPA uses in risk
characterization and a complete description of the risk assessment
process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for ADBAC used for human
risk assessment is shown in the Table in this unit.
Summary of Toxicological Doses and Endpoints for ADBAC for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of Departure and
Exposure/Scenario Uncertainty/Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General pop., females An acute dietary endpoint was not identified in the database.
13+, infants and children)
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 44 mg/kg/day Chronic RfD = 0.44 mg/ Chronic toxicity/
UFA = 10x.............. kg/day carcinogencity-rat
UFH = 10x.............. cPAD = 0.44 mg/kg/day.. MRID 41947501
FQPA SF = 1x........... LOAEL = 88 mg/kg/day
based on decreased
body weight and weight
gain
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to 30 NOAEL = 10 mg/kg/day LOC for MOE = 100 Developmental Toxicity-
days) UFA = 10x.............. Rat MRID 42351501
UFH = 10x.............. LOAEL = 30 mg/kg/day
FQPA SF = 1x........... based on clinical
signs and decrease
body weight gain
----------------------------------------------------------------------------------------------------------------
Incidental oral intermediate-term (1 NOAEL = 10 mg/kg/day LOC for MOE = 100 Developmental Toxicity-
to 6 months) UFA = 10x.............. Rat MRID 42351501
UFH = 10x.............. LOAEL = 30 mg/kg/day
FQPA SF = 1x........... based on clinical
signs and decrease
body weight gain
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days) Dermal study LOC for MOE = 10 d 21-day dermal toxicity-
(Formulated product (4% ai.)) NOAEL = 20 mg/kg/day... guinea pigs MRID
(333 [mu]g/cm2)b....... 41105801
UFA = 3 x.............. LOAEL = 40 mg/kg/day
UFH = 3x............... based on denuded non-
FQPA SF = 1x........... vascularized epidermal
layer
----------------------------------------------------------------------------------------------------------------
Dermal intermediate-term (technical Dermal study LOC for MOE = 10 d 90-day dermal in rats
grade a.i.) (1 to 6 months) NOAEL = 20 mg/kg/day... MRID 41499601
(80 [mu]g/cm2)c........ LOAEL = 20 mg/kg/day
UFA = 3 x.............. based on highest doest
UFH = 3x............... tested before
FQPA SF = 1x........... irritation became
significant.
Irritation not
observed until day 43
----------------------------------------------------------------------------------------------------------------
Dermal Short-term (technical grade No endpoint identified from the available data on dermal irritation.
a.i) Dermal irritation in the 90-day dermal toxicity study was not evident
until day 43 (MRID 41499601)d
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (technical grade No appropriate endpoint identified. No systemic effects observed up to 20
a.i.) mg/kg/day, highest dose of technical that could be tested without
irritation effects.d
----------------------------------------------------------------------------------------------------------------
[[Page 49104]]
Inhalation (all exposures) Oral study NOAEL = 3 mg/ LOC for MOE = 1,000 Developmental Toxicity-
kg/day 100%) rabbit MRID 42392801
UFA = 10x.............. LOAEL = 9 mg/kg/day
UFH = 10 x............. based on clinical
UF =10xa............... signs of toxicity in
FQPA SF = 1x........... maternal animals
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE =
margin of exposure. LOC = level of concern.
a An additional uncertainity factor of 10x is applied for use of an oral endpoint for route-to-route
extrapolation to determine if a confirmatory inhalation toxicity study is warranted.
b Formulated-based dermal endpoint = (20 mg/kg guinea pig x 0.43 kg guinea pig x 1,000 [mu]g/mg)/ 25.8 cm2 area
of guinea pig dosed = 33 [mu]g/cm2.
c TGAI-based dermal endpoint = (20 mg/kg rat x 0.2 kg rat x 1,000 [mu]g/mg)/ 50 cm2 area of rate dosed = 80
[mu]g/cm2.
d For dermal exposures, irritation as the effect was selected for the short-term endpoint and a reduced margin
of exposure (MOE) was used to characterize the risk. The use of irritation as a toxic endpoint for assessment
of dermal risk is appropriate in this case, as dermal exposure that results in primarily an irritation
response is considered a self-limiting type of exposure that is not expected to last for any length of time,
and variability in the response is not expected to be as great as systemic toxic responses. For ADBAC, the MOE
for short-term dermal risk is reduced to a total factor of 10x( 3x for interspecies extrapolation, 3x for
intraspecies variation
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to n-Alkyl (C12-18) Dimethyl Benzyl Ammonium
Chloride, EPA considered exposure under the petitioned-for exemption as
well as all existing ADBAC exemptions or tolerances in (40 CFR
180.940(a), and (c)). EPA assessed dietary exposures from ADBAC in food
as follows:
ADBACs are to be used as a sanitizer on counter tops, utensils,
appliances, tables, refrigerators, food packaging, and beverage
bottling. The use of these actives in antimicrobial products for use on
food or feed contact surfaces, agricultural commodities, and
application to food-grade eggs may result in pesticide residues in
human food. Residues from treated surfaces, such as utensils,
countertops, equipment, and appliances can migrate to food coming into
contact with the treated and rinsed surfaces and can be ingested by
humans.
The Agency assessed chronic dietary exposures from the use of ADBAC
as a disinfectant and food contact sanitizer on utensils, countertops,
and in food/beverage processing facilities. The assessment calculated
the Daily Dietary Dose (DDD) and the Estimated Daily Intake (EDI) using
modified FDA methodologies for utensils and Indirect Dietary
Residential Exposure Model software (IDREAM) for countertops. IDREAM
incorporates consumption data from USDA's Continuing Surface of Food
Intakes by Individuals (CSFII) for 1994-1996, and 1998. The 1994-1996,
and 1998 data are based on the reported consumption of more than 20,000
individuals over two non-consecutive survey days.
The Estimated Daily Intake (EDI) calculations presented in this
assessment for treated indirect dietary exposures resulting from
sanitizing utensils assumed that food would contact 4,000
cm2 (which represents contact with treated silverware,
china, and glass used by an individual who regularly eats three meals
per day at an institutional or public facility) and that the residual
solution remaining on the surface or pesticide migration fraction is 1
milligram (mg) per square centimeter of treated area. The body weights
used for this assessment were 70 kilogram (kg) for an adult male, 60 kg
for an adult woman, and 10 kg for an infant. Based on data provided in
a new residue study, Transferability Equivalence among Quats and
Measured Food Surrogate Transfer Efficiency (MRID 46870703), a
conservative transfer rate of 43% was used to estimate the amount of
residues on the surface that will be transferred to food and
subsequently ingested. The maximum application rate for ADBAC on
utensils is 0.0033 lbs a.i per gallon of treatment solution.
There are two levels of refinement for assessing dietary exposure
to antimicrobial products used on countertops. The three dimensional
approach, Tier 2, was utilized for this assessment. This conservative
approach uses food consumption and preparation patterns as well as data
and assumptions that are not chemical specific. Food ingredients are
separated into nine categories based on food preparation, food physical
properties, and potential, or likelihood of contact with treated
countertops. The nine food categories are liquids, fruit, bread,
cheese, vegetable, meat, purees (e.g., pudding, oatmeal), pieces (foods
normally consumed in small pieces), and powders (foods normally used in
powder/granular forms). Assumed countertop residues are converted to
estimated residues contacting the countertops using a translation
factor for each food category, and default residue transfer efficiency
for a representative food. Therefore, IDREAM combines the estimated
countertop residues for surface treatment products, CSFII consumption
data, food-specific conversion factors that relate the surface area
contacting a countertop with corresponding weight of the food item, and
the transfer efficiency of residues from countertops to food.
Conservative assumptions for these analyses include: All disinfectants
registered to disinfect kitchen countertops are included; all foods are
prepared on treated countertops; all prepared foods will come in
contact with treated countertops at the maximum active ingredient
residues; these residues will not diminish over time (i.e. residue
reduction will not occur from cooking or preparation processes); there
is a 100% likelihood of contact to account for both commercial and
residential scenarios; all commercial facilities and households use the
same disinfectant product; all foods are prepared and consumed.
When assessing the food bottling/packaging use, EPA assumed a 100%
transfer rate because the food is potentially in contact with the
treated surfaces for very long periods of time. The maximum application
rate for ADBAC for bottling/packing of food is 0.0103 lbs a.i per
gallon of treatment solution. EDI values were calculated
[[Page 49105]]
using an approach similar to that used for treated food utensils.
Exposure was assumed to occur through the ingestion of three food
products that might be packaged in treated material: Milk, egg
products, and beverages (alcoholic and non-alcoholic). A calorie intake
modification factor of 0.64 was applied to the EDI for a child to
account for the differences between intake values among children and
adults. The calculated % cPADs for all population subgroups do not
exceed 100% and therefore are not of a concern.
2. Dietary exposure from drinking water. ADBAC is applied to
nursery ornamentals and turf as an bactericide and fungicide. The Tier
1 surface water and ground water model was used to assess Estimated
Drinking Water Concentrations (EDWCs). EPA modeled the ornamental plant
use because this use has the highest application rate of all labeled
uses -- 302 lbs. a.i/Acre, and a maximum of three applications per
year. The EDWCs determined for the nursery ornamental use are also
protective of all other uses with lower application rates. The EDWC for
surface water is 331 microgram/Liter ([mu]g/L) and ground water is 5.4
[mu]g/L. There were no major degradates of ADBAC in the laboratory
studies.
ADBAC is also used for mosquito control and as an algaecide in
decorative ponds and pools. Because the mosquito control and algaecide
uses are both periodic in nature and are restricted to a limited use
area, EPA expects drinking water exposures from these uses to be
minimal in comparison to the ornamental plant exposure estimate for
drinking water using the tier I surface and ground water model.
Additionally, antisapstain and cooling water tower uses for ADBAC are
potential exposures to drinking water. These uses are also expected to
result in minimal exposure in comparison to the modeled EDWCs for the
ornamental use taking into account that the Tier 1 model assumed that
ADBAC was applied at 302 pounds/acre across the entire watershed.
Specific information on the dietary and drinking water exposure
assessments for ADBAC can be found at https://www.regulations.gov.
Docket ID Number EPA-HQ-OPP-2006-0339 Dietary Risk Assessment on ADBAC
and Tier 1 Drinking Water Assessment for Alkyl Dimethyl Benzyl Ammonium
Chloride (ADBAC) and Didecyl Dimethyl Ammonium Chloride (DDAC).
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
ADBAC is currently registered for the following residential non-
dietary sites: Homes, swimming pools, humidifiers. EPA assessed
residential exposure using the following assumptions: Residential
exposure may occur during the application as well as post application
of ADBAC to indoor hard surfaces (e.g., mopping, wiping, trigger pump
sprays), carpets, swimming pools, wood as a preservative, textiles
(e.g., diaper treated during washing and clothes treated with fabric
spray), and humidifiers. The residential handler scenarios were
assessed to determine dermal and inhalation exposures. Residential post
application scenarios such as children exposure to treated toys and
floors were also assessed to determine dermal and incidental oral
exposures. Surrogate dermal and inhalation unit exposure values were
estimated using Pesticide Handler Exposure Database (PHED) data and the
Chemical Manufactures Association Antimicrobial Exposure Assessment
Study (USEPA, 1999), and the SWIMODEL 3.0 was utilized to conduct
exposure assessments of pesticides found in swimming pools and spas
(Versar, 2003). Note that for this assessment, EPA assumed that
residential users complete all elements of an application (mix/load/
apply) without the use of personal protective equipment.
The duration for most residential exposures is believed to be best
represented by the short-term duration (1 to 30 days). The short-term
duration was chosen for this assessment because the residential handler
and post-application scenarios are assumed to be performed on an
episodic, not daily basis.
Specific information on the residential exposure assessment for
ADBAC Quaternaries can be found at https://www.regulations.gov. Docket
ID Number EPA-HQ-OPP-2006-0339 Alkyl Dimethyl Benzyl Ammonium Chloride
(ADBAC) Occupational and Residential Exposure Assessment.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA's risk assessment for any individual ADBAC is based on an
assessment of the cumulative exposure to all ADBACs. The individual
exposure scenarios in the ADBAC assessments (as well as the aggregate
assessment in the RED) were developed by assuming that an ADBAC
compound was used on 100 percent of the surfaces authorized on the
label that could result in human exposure and summing the percent
active ingredients on the labels for all of the ADBACs when used in
combination. Thus, because the risk assessment for ADBAC accounts for
exposures to all of the ADBACs, there is no need for a separate
cumulative risk assessment for those compounds. The Agency has not
identified any other substances as sharing a common mode of toxicity
with ADBAC. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (10X) tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA SF. In applying this
provision, EPA either retains the default value of 10X when reliable
data do not support the choice of a different factor, or, if reliable
data are available, EPA uses a different additional FQPA SF value based
on the use of traditional UFs and/or FQPA SFs, as appropriate.
2. Prenatal and postnatal sensitivity. There is no evidence that
ADBAC result in increased susceptibility in in utero rats or rabbits in
the prenatal developmental studies or in young rats in the 2-generation
reproduction study.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA SF to 1X.
That decision is based on the following findings:
i. The toxicity database for ADBAC pertaining to the risks to
infants and childrenis complete.
ii. There is no indication that ADBAC is a neurotoxic chemical and
there is no need for a developmental neurotoxicity study or additional
UFs to account for neurotoxicity.
iii. There is no evidence that ADBAC results in increased
susceptibility in in utero rats or rabbits in the prenatal
[[Page 49106]]
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. Conservative ground water and surface water modeling
estimates were used. Similarly conservative residential standard
operating procedures (SOPs) were used to assess post-application
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by ADBAC.
E. Aggregate Risks and Determination of Safety
The chronic dietary aggregate risk assessment includes direct and
indirect food contact uses as well as drinking water exposures. Based
on the results of the chronic aggregate assessment, the estimated
chronic risks for adults and children are 8.4% and 40.9% of the
respective cPADs. Therefore, the chronic dietary aggregate risks are
not of concern (i.e., less than 100% of cPAD).
Short-term and intermediate-term aggregate risks were calculated
using the total MOE approach. Only the short-term aggregate is
presented here because the endpoints for incidental oral as well as
inhalation are identical for the short- and intermediate-term
durations. Moreover, EPA has not identified that aggregate risks are
not of concern for adults for any of the three routes of exposure. The
aggregate adult MOEs are 1,200 for oral, 480 for dermal, and 2,000 for
inhalation, which are greater than the target MOE of 100 for the oral,
1,000 for inhalation, and 10 for dermal. For children, the aggregate
risk estimate for each of the routes of exposure are also above the
target MOEs of 100 for the oral, 1,000 for inhalation, and 10 for
dermal (MOE = 140 for the oral route, 1,200 for the dermal route, and
no co-occurrence for the inhalation route), and thus are not of
concern.
Based on the toxicological and exposure data discussed in this
preamble, EPA concludes that ADBAC will not pose a risk under
reasonably foreseeable circumstances. Accordingly, EPA finds that there
is a reasonable certainty of no harm will result to the general
population, or to infants and children from aggregate exposure to ADBAC
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An analytical method for food is not needed for enforcement
purposes. Food contact sanitizers are typically regulated by the State
health departments to ensure that the food industry is using products
in compliance with the regulations in 40 CFR 180.940. The end-use
solution that is applied to the food contact surface is analyzed,
rather than food items that may come into contact with treated surface.
An analytical method is available to analyze the use dilution that is
applied to food contact surfaces. A titration method is used to
determine the total amount of quaternary compound. If the use solution
is a mixture of ADBAC and didecyl dimethyl ammonium chloride (DDAC),
then High Pressure Liquid Chromatogram-Ultraviolet Visible (HPLC-UV) is
used to determine the amount of ADBAC. The amount of DDAC is determined
by calculating the difference between the total amount of quaternary
compounds and ADBAC.
B. Revisions to Petitioned-For Exemption
EPA has revised the exemption as proposed in the notice of filing.
The petitioner proposed to amend the exemption for Quaternary Ammonium
Compounds: N-alkyl (C12-18) dimethyl benzyl ammonium
chloride by increasing the amount of quaternary chemicals that may be
in end-use concentrations from 200 ppm to 400 ppm. There presently
exists an exemption for Quaternary Ammonium Compounds: Alkyl
(C12-18) dimethyl benzyl ammonium chloride (CAS Reg. No.
8001-54-5) that limits the concentration of quaternary chemicals to 200
ppm; however, because the petitioner specifically sought an exemption
for Quaternary Ammonium Compounds: N-alkyl (C12-18) dimethyl
benzyl ammonium chloride (CAS Reg. No. 68424-85-1) with a limit for the
concentration of quaternary chemicals at 400 ppm, EPA has not amended
the existing exemptions but instead established a new exemption for
Quaternary Ammonium Compounds: N-alkyl (C12-18) dimethyl
benzyl ammonium chloride (CAS Reg. No. 68424-85-1).
V. Conclusion
Therefore, an exemption from the requirement of a tolerance under
section 408 of FFDCA is established for residues of n-alkyl
(C12-18) dimethyl benzyl ammonium chloride (CAS No. 68424-
85-1), on food contact surfaces resulting from use as an antimicrobial
pesticide formulation applied to food-contact surfaces in public eating
places, dairy processing equipment, and food processing equipment and
utensils, provided that the end-use concentration of all quaternary
chemicals in solution does not exceed 400 ppm of active quaternary
compound.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the
[[Page 49107]]
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Alkyl Dimethyl Benzyl Ammonium Chloride
Quaternaries, Food Additives, Food-Contact Sanitizers Pesticides and
pests, Reporting and recordkeeping requirements.
Dated: August 7, 2008.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.940 is amended by alphabetically adding a new entry in
the table in paragraph (a) to read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
(a) * * *
------------------------------------------------------------------------
Pesticide Chemical CAS Reg. No. Limits
------------------------------------------------------------------------
* * * * *
Quaternary Ammonium Compounds: n- 68424-85-1 When ready for
alkyl (C12-18) dimethyl benzyl use, the end-use
ammonium chloride concentration of
all quaternary
chemicals in
solution is not
to exceed 400 ppm
of active
quaternary
compound.
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-19070 Filed 8-19-08; 8:45 am]
BILLING CODE 6560-50-S
